notyard
09-04-2008, 08:14 AM
FDA class II recall:
PRODUCT
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008
CODE
10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198
RECALLING FIRM/MANUFACTURER
Tomo Therapy Inc., Madison, WI, by letter dated February 22, 2008. Firm initiated recall is ongoing.
REASON
In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number "8" may appear as the number "0" on the printed page. During the registration process, the HI-ART couch will achieve the accepted and approved registered position automatically. However, if the operator subsequently adjusts the couch position manually based on a printout with the anomaly, the patient may be in the incorrect position during treatment.
VOLUME OF PRODUCT IN COMMERCE
32 systems
DISTRIBUTION
Nationwide and Internationally
PRODUCT
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008
CODE
10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198
RECALLING FIRM/MANUFACTURER
Tomo Therapy Inc., Madison, WI, by letter dated February 22, 2008. Firm initiated recall is ongoing.
REASON
In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number "8" may appear as the number "0" on the printed page. During the registration process, the HI-ART couch will achieve the accepted and approved registered position automatically. However, if the operator subsequently adjusts the couch position manually based on a printout with the anomaly, the patient may be in the incorrect position during treatment.
VOLUME OF PRODUCT IN COMMERCE
32 systems
DISTRIBUTION
Nationwide and Internationally